What question did this study set out to answer?

To assess the antithrombotic efficacy, pharmacodynamics, and safety of oral betrixaban compared with enoxaparin for preventing venous thromboembolism following elective total knee replacement.

December 10, 2008Thrombosis and Haemostasis

A randomized evaluation of betrixaban, an oral factor Xa inhibitor, for prevention of thromboembolic events after total knee replacement (EXPERT)

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Why the study?

Does betrixaban prevent venous thromboembolism in patients undergoing elective total knee replacement compared to enoxaparin?

Population

215 patients undergoing elective total knee replacement (TKR)

Comparison

Post-operative betrixaban 15 mg or 40 mg oral… vs Enoxaparin 30 mg subcutaneous every 12 hours for…

Design

RCT, 2:2:1 ratio, Betrixaban dosage was blinded, but enoxaparin was not…

Follow-up

10-14 days

Authors

KBKenneth BauerBeth Israel Deaconess Medical Center BDBruce L. DavidsonVascular / Pulmonary Vascular MGMichael GentUniversité Claude Bernard Lyon 1

Discussion

Member takes

Implication

Higher VTE rates with betrixaban versus enoxaparin after TKR suggest suboptimal efficacy; extends phase 2 dose-response data but leaves optimal regimen open.

Key Points

To assess the antithrombotic efficacy, pharmacodynamics, and safety of oral betrixaban compared with enoxaparin for preventing venous thromboembolism following elective total knee replacement.
Randomized trial conducted in the US and Canada enrolling 215 patients undergoing elective total knee replacement assigned 2:2:1 to post-operative oral betrixaban (15 mg or 40 mg twice daily; blinded dosage) or subcutaneous enoxaparin (30 mg every 12 hours; open-label) for 10-14 days.
Primary efficacy was venous thromboembolism (mandatory unilateral venography-detected deep-vein thrombosis, symptomatic proximal deep-vein thrombosis, or pulmonary embolism) through Days 10-14; safety outcomes included major and clinically significant non-major bleeding adjudicated by a blinded committee.
Venous thromboembolism incidence among evaluable patients (N=175) occurred in 14/70 (20%; 95% CI: 11, 31) with betrixaban 15 mg, 10/65 (15%; 95% CI: 8, 27) with betrixaban 40 mg, and 4/40 (10%; 95% CI: 3, 24) with enoxaparin.
Clinically significant non-major bleeding occurred in 0/70 (0%) with betrixaban 15 mg, 2/84 (2.4%) with betrixaban 40 mg, and 2/43 (4.6%) with enoxaparin, with major bleeding occurring only in the enoxaparin group (1/43; 2.3%).
Betrixaban produced a dose- and concentration-dependent inhibition of thrombin generation and anti-factor Xa levels.

Structured PICO

Does betrixaban prevent venous thromboembolism in patients undergoing elective total knee replacement compared to enoxaparin?

Population

215 patients undergoing elective total knee replacement (TKR)

Intervention

Post-operative betrixaban 15 mg or 40 mg oral twice daily for 10-14 days

Comparator

Enoxaparin 30 mg subcutaneous every 12 hours for 10-14 days

Outcome

Incidence of VTE, consisting of deep-vein thrombosis (DVT) on mandatory unilateral (operated leg) venography, symptomatic proximal DVT, or pulmonary embolism (PE) through Day 10-14composite

Betrixaban demonstrated dose-dependent antithrombotic activity and appeared well tolerated for VTE prevention after total knee replacement.

Cite This Study

Bauer et al. (2008) studied this question.

synapsesocial.com/papers/6a804d85d82d8273d046f8ad https://doi.org/10.1160/th08-07-0460

Topics

Pulmonary embolism

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Implication

Higher VTE rates with betrixaban versus enoxaparin after TKR suggest suboptimal efficacy; extends phase 2 dose-response data but leaves optimal regimen open.

A randomized evaluation of betrixaban, an oral factor Xa inhibitor, for prevention of thromboembolic events after total knee replacement (EXPERT)

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Topics

A randomized evaluation of betrixaban, an oral factor Xa inhibitor, for prevention of thromboembolic events after total knee replacement (EXPERT)

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Also Consider

Topics

Also Consider